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BMC Neurology
Published in: BMC Neurology 1/2015

Open Access 01-12-2015 | Study protocol

Serum biomarkers for the early diagnosis of TIA: The MIND-TIA study protocol

Authors: L. Servaas Dolmans, Frans H. Rutten, Marie-Louise EL Bartelink, Gerdien Seppenwoolde, Sanne van Delft, L. Jaap Kappelle, Arno W. Hoes

Published in: BMC Neurology | Issue 1/2015

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Abstract

Background

A Transient Ischaemic Attack (TIA) bears a high risk of a subsequent ischaemic stroke. Adequate diagnosis of a TIA should be followed immediately by the start of appropriate preventive therapy, including antiplatelets. The diagnosis of a TIA based on symptoms and signs only is notoriously difficult and biomarkers of brain ischaemia might improve the recognition, and target management and prognosis of TIA patients. Our aim is to quantify the added diagnostic value of serum biomarkers of brain ischaemia in patients suspected of TIA.

Methods/design

Study design: a cross-sectional diagnostic accuracy study with an additional six month follow-up period.
Study population: 350 patients suspected of TIA in the primary care setting.
Patients suspected of a TIA will be recruited by at least 200 general practitioners (GPs) in the catchment area of seven TIA outpatient clinics willing to participate in the study. In all patients a blood sample will be drawn as soon as possible after the patient has contacted the GP, but at least within 72 h after onset of symptoms. Participants will be referred by the GP to the regional TIA outpatient clinic for additional investigations, including brain imaging. The ‘definite’ diagnosis (reference standard) will be made by a panel consisting of three experienced neurologists who will use all available diagnostic information and the clinical information obtained during the outpatient clinic assessment, and a six month follow-up period. The diagnostic accuracy, and value in addition to signs and symptoms of candidate serum biomarkers will be assessed in terms of discrimination with C statistics, and calibration with plots.
We aim to include 350 suspected cases, with 250 patients with indeed definite TIA (or minor stroke) according to the panel.

Discussion

We hope to find novel biomarkers that will enable a rapid and accurate diagnosis of TIA. This would largely improve the management and prognosis of such patients.

Trial registration

ClinicalTrials.gov Identifier NCT01954329
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Metadata
Title
Serum biomarkers for the early diagnosis of TIA: The MIND-TIA study protocol
Authors
L. Servaas Dolmans
Frans H. Rutten
Marie-Louise EL Bartelink
Gerdien Seppenwoolde
Sanne van Delft
L. Jaap Kappelle
Arno W. Hoes
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Neurology / Issue 1/2015
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/s12883-015-0388-z

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